In-House CRA
Technical Resources International, Inc.
Summary
The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties.
Job description
Duties may include but are not limited to:
- Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor/Client.
- Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.
- Track essential regulatory documents in a centralized web-based system and/or other database.
- Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems.
- Coordinate or assist in distribution of trial-related materials to study sites.
- May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation.
NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.
Job Requirements
- Understanding of medical and clinical trials terminology.
- Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution.
- Able to work independently or with minimal supervision as well as within a team.
- Excellent attention to detail with organizational and prioritization skills for efficient productivity.
- Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).
- Excellent professional writing and verbal communication skills (position requires clear phone and email communication).
- Able to multi-task during the review/processing and preparation of essential regulatory documentation.
- Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.
- Must have excellent time management skills, able to adhere to strict timelines and expectations.
- Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.
- Experience with using a Trial Master File, a plus.
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Requirements
- Understanding of medical and clinical trials terminology
- Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution
- Able to work independently or with minimal supervision as well as within a team
- Excellent attention to detail with organizational and prioritization skills
- Proficiency with Microsoft Office (MS Word, Excel, Outlook at a minimum)
- Excellent professional writing and verbal communication skills
- Able to multi-task during the review/processing and preparation of essential regulatory documentation
- Must be self-motivated with a positive attitude
- Must have excellent time management skills and adhere to strict timelines
- Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
- Experience with using a Trial Master File, a plus
Company overview
Technical Resources International, Inc. (TRI) is a leading contract research organization plus (CRO+) founded in 1979 and headquartered in Bethesda, Maryland. As a certified Hispanic woman-owned business, TRI provides comprehensive product development support services to pharmaceutical, biotechnology, vaccine, medical device, and healthcare sector clients worldwide. The company specializes in the effective integration of scientific, clinical, information technology, and communication services to accelerate drug development and regulatory approval processes. TRI offers end-to-end solutions including clinical trial management across all phases (I-IV), regulatory strategy and operations, biostatistics, data management, medical writing, and safety monitoring. With over four decades of experience, TRI has established itself as a trusted partner to both public and private sector clients, including major government agencies like the National Institutes of Health (NIH) and National Cancer Institute. The company's success is built on its staff's scientific expertise, client-focused approach, and proven track record of delivering high-quality services that meet regulatory standards and accelerate time-to-market for innovative therapies.